Indicated for:

Primary Hypercholesterolemia or Mixed Dyslipidemia:

• Adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

Severe Hypertriglyceridemia:

• Adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia.

Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

The effect of TRICOR on coronary heart disease morbidity and mortality and non cardiovascular mortality has not been established.

Fenofibrate at a dose equivalent to 145 mg of TRICOR was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus.

Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

The use of TRICOR should be avoided in patients with severe renal impairment.

Serious drug-induced liver injury (DILI), including liver transplantation and death, have been reported postmarketing with TRICOR. DILI has been reported within the first few weeks of treatment or after several months of therapy and in some cases has reversed with discontinuation of TRICOR treatment.

In clinical trials, fenofibrate at doses equivalent to 96 mg to 145 mg TRICOR daily has been associated with increases in serum AST or ALT. The incidence of increases in transaminases may be dose related

Fibrates increase the risk for myopathy and have been associated with rhabdomyolysis. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal insufficiency, or hypothyroidism.

Pulmonary embolus (PE) and deep vein thrombosis (DVT) were observed at higher rates in the fenofibrate- than the placebo-treated group.

Hepatocellular, chronic active and cholestatic hepatitis associated with fenofibrate therapy have been reported after exposures of weeks to several years. In extremely rare cases, cirrhosis has been reported in association with chronic active hepatitis.

Elevations in serum creatinine have been reported in patients on fenofibrate.

Fenofibrate, like clofibrate and gemfibrozil, may increase cholesterol excretion into the bile, leading to cholelithiasis.

Pancreatitis has been reported in patients taking fenofibrate, gemfibrozil, and clofibrate.

Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported postmarketing, occurring days to weeks after initiation of fenofibrate.

Thrombocytopenia and agranulocytosis have been reported in individuals treated with fenofibrate. Periodic monitoring of red and white blood cell counts are recommended during the first 12 months of TRICOR administration.

If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated.

TRICOR is contraindicated in patients with:

• Severe renal impairment, including those receiving dialysis
• Active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities 
• Preexisting gallbladder disease 
• Nursing mothers  

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine.

Caution should be exercised when coumarin anticoagulants are given in conjunction with TRICOR because of the potentiation of coumarin-type anticoagulant effects in prolonging the Prothrombin Time/International Normalized Ratio (PT/INR).

The risk for rhabdomyolysis is increased when fibrates, in particular gemfibrozil, are co-administered with an HMG-CoA reductase inhibitor (statin). The combination should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination.

Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including TRICOR, there is a risk that an interaction will lead to deterioration of renal function.

Since bile acid binding resins may bind other drugs given concurrently, patients should take TRICOR at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.

Safety in pregnant women has not been established. Animal studies: maternal toxicity.

Because of the potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment with TRICOR and for 5 days after the final dose.

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• Dosage greater than 160 mg per day in patients with normal renal function. GoToSource

• Use in patients under the age of 18. GoToSource

• Diabetic retinopathy. GoToSource

• Hyperuricemia and gout. GoToSource

• Primary biliary cirrhosis in patients having a partial response to standard dose of ursodeoxycholic acid for at least one year. GoToSource

• Severely burned patients to improve hyperglycemia and insulin resistance. GoToSource

• Recurrent embryonal brain tumors. GoToSource

• AF prevalence in patients with reduced left ventricular ejection fraction. GoToSource

Mycophenolate induced neutropenia (low number of neutrophils, a type of white blood cell). GoToSource

Increased creatinine plasma. GoToSource

Myopathy (disorder of skeletal muscles). GoToSource

Gallbladder stones. GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Rhabdomyolysis (severe atrophy of skeletal muscle tissue). GoToSource 

Impotence, insomnia, gastrointestinal dysfunction and rash. GoToSource

Decline in visual memory. GoToSource

Liver injury. GoToSource

Generalized exanthematous pustulosis (severe skin reaction). GoToSource 

Thrombocytopenia (low blood platelet count). GoToSource

Agranulocytosis (decreased number of granulocytes, a type of white blood cell). GoToSource

Increased risk of pulmonary embolus and venous thromboembolism. GoToSource

Kidney failure. GoToSource

Lawsuits filed for liver damage, memory loss, muscle damage, cardiomyopathy and diabetes.